A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Bendamustine Hydrochloride

Criteria

Inclusion Criteria:

• Adult Filipino patients with chronic lymphocytic leukemia

• Patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic Binet stage B or C) and for whom fludarabine combination chemotherapy is not appropriate

• World health organization performance Status of 0, 1, or 2

• Need-to-treat criteria in B-cell chronic lymphocytic leukemia

Exclusion Criteria:

• Had received previous treatment with other cytotoxic drugs

• Had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)

• Concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection

• Patients with severe renal and hepatic impairment

• Patients with severe bone marrow suppression and severe blood count alterations

• Pregnant women and lactating mothers